CurrentAetnaPolicy 0375

Photodynamic Therapy

This Aetna Clinical Policy Bulletin (0375) defines medical necessity criteria, investigational/excluded indications, and coding guidance for photodynamic therapy (topical and intravenous photosensitizers) for commercial medical plans. It includes covered indications (esophageal cancer, lung cancer, certain non-melanoma skin tumors, cholangiocarcinoma) with criteria, lists of covered and not-covered CPT/HCPCS/ICD-10 codes, and background/evidence discussion.

Policy Summary

PayerAetna

PolicyPhotodynamic Therapy

Policy CodePolicy 0375

Change TypeNo material change

Effective DateJan 31, 2000

Next Review DateApr 11, 2024

Key ActionProvider must document that the patient's diagnosis and clinical situation meet the listed medical necessity criteria (e.g., obstruction status, Barrett's esophagus ineligible for esophagectomy, inability to use Nd:YAG for esophageal partial obstruction, inoperable cholangiocarcinoma with stenting).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

4Medically necessary indications listed

~40+Investigational/Not covered indications listed

MultipleCode groups present

predominantly lowEvidence strength

Policy active period

Coverage Summary

This document is Aetna Clinical Policy Bulletin 0375 addressing photodynamic therapy (PDT) for commercial medical plans. Scope: the policy defines medical necessity criteria for specific covered indications (notably certain esophageal cancer, endobronchial non-small cell lung cancer, selected non-melanoma skin tumors using topical photosensitizers, and PDT as an adjunct to stenting for inoperable cholangiocarcinoma), lists investigational/excluded indications (many cancer and non-cancer uses), and provides coding guidance. Policy status is CURRENT with policy number 0375; effective date 2000-01-31; last review date 2023-06-21.

Photodynamic Therapy - Key Policy Metadata

PolicyPhotodynamic Therapy

PayerAetna

Policy Number0375

Effective Date2000-01-31

Last Review2023-06-21

Next Review2024-04-11

Coverage stancemixed

Medically necessary indications listed4

Medical-Necessity Criteria

Esophageal Cancer - Medical Necessity

Covered when ANY of the following are met:

ANY of the following

Barrett's esophagus carcinoma in-situ and high-grade disease in members who are not candidates for esophagectomy.
Completely obstructing esophageal cancer.
Partially obstructing esophageal cancer, in members who cannot be satisfactorily treated with Nd:YAG laser therapy.

Lung Cancer (endobronchial non-small cell) - Medical Necessity

Covered when ANY of the following are met:

ANY of the following

Not Covered / Experimental Indications

Experimental and Investigational - Cancer Indications (Not Covered)

PDT is considered experimental and investigational for ANY of the following cancer indications:

ANY of the following

Brain tumors (e.g., glioma)
Breast cancer
Cervical intraepithelial neoplasia/cervical cancer
Colon cancer
Gastric cancer

Coding

CPT codes covered if selection criteria are met (endoscopic Photofrin PDT)CPTCovered

96570	Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s); first 30 minutes (list separately in addition to code for endoscopy or bronchoscopy procedures of lung and esophagus).
96571	Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s); each additional 15 minutes (list separately in addition to code for endoscopy or bronchoscopy procedures of lung and esophagus).

HCPCS / J-codes covered if selection criteria are met (porfimer sodium and topical ALA/MAL)HCPCS|NDC|mixedCovered

J9600	Porfimer sodium, 75 mg.
J7308	Aminolevulinic acid HCL for topical administration, 20%, single unit dosage form (354 mg).
J7345	Aminolevulinic acid hcl for topical administration, 10% gel, 10 mg.

CPT codes covered if selection criteria are met (external/topical PDT)CPTCovered

96567	Photodynamic therapy by external application of light to destroy pre-malignant and/or malignant lesions of the skin and adjacent mucosa (e.g., lip) by activation of photosensitive drug(s) each phototherapy exposure session.
96573	Photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified health care professional, per day.
96574	Debridement of premalignant hyperkeratotic lesion(s) followed with Photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified health care professional, per day.

Other related CPT codes (procedures that may accompany PDT)CPT

31641	Bronchoscopy (rigid or flexible); with destruction of tumor or relief of stenosis by any method other than excision (e.g., laser therapy, cryotherapy).
43228	Esophagoscopy, rigid or flexible; with ablation of tumor(s), polyp(s), or other lesion(s), not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique.
43229	Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed).
43270	Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed).
43278	ERCP; with ablation of tumor(s), polyp(s), or other lesion(s), including pre- and post-dilation and guide wire passage, when performed.
43272	ERCP; with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique.

HCPCS / J-codes not covered (discontinued or not covered for listed indications)HCPCSNot Covered

J7309

Methyl aminolevulinate (MAL) for topical administration, 16.8%, 1 gram [product discontinued].

ICD-10 codes covered when selection criteria are met (esophagus, lung, skin, cholangiocarcinoma)ICD-10Covered

C15.3 - C15.9	Malignant neoplasm of esophagus [obstructing].
C34.00 - C34.92	Malignant neoplasm of bronchus and lung [microinvasive endobronchial non-small cell] [obstructing].
D00.1	Carcinoma in situ of esophagus [Barrett's].
C44.01	Basal cell carcinoma (covered when criteria met).
C44.111 - C44.119	Basal cell carcinoma codes (covered when criteria met).
C44.211 - C44.219	Basal cell carcinoma codes (covered when criteria met).
C44.310 - C44.319	Basal cell carcinoma codes (covered when criteria met).
C44.510 - C44.519	Basal cell carcinoma codes (covered when criteria met).
C44.611 - C44.619	Basal cell carcinoma codes (covered when criteria met).
C44.711 - C44.719	Basal cell carcinoma codes (covered when criteria met).

1–10 of 16

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ICD-10 codes not covered for indications listed in CPB (examples, not all-inclusive)ICD-10Not Covered

C43.0 - C43.9	Malignant melanoma and melanoma in situ of skin (not covered).
D03.0 - D03.9	Melanoma in situ (not covered).
A63.0	Anogenital (venereal) warts.
B00.1	Herpesviral vesicular dermatitis.
B07.0	Plantar wart.
B07.8	Other viral warts [verrucous vulgaris of the face].
B35.0, B35.1, B35.3, B35.6	Dermatophytosis (superficial mycosis).
B36.0	Pityriasis versicolor [superficial mycosis].
B97.7	Papillomavirus as the cause of diseases classified elsewhere.
C21.0	Malignant neoplasm of anus.

1–10 of 46

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Provider Actions & Billing Guidance

Documentation Required

Demonstrate criteria for covered indications

Document in the medical record that the patient's diagnosis and clinical situation meet the policy's medical necessity criteria. Include specifics that map to covered indications such as obstruction status (completely or partially obstructing lesions), Barrett's esophagus when the patient is not a candidate for esophagectomy, inability to use Nd:YAG laser therapy for partially obstructing esophageal cancer, or inoperable cholangiocarcinoma being treated adjunctively with stenting.

Completely or partially obstructing esophageal cancer; note if Nd:YAG is not an option
Barrett's esophagus carcinoma in-situ / high-grade disease in patients not candidates for esophagectomy
Inoperable cholangiocarcinoma receiving PDT as an adjunct to stenting

Billing Rule

Report endoscopic PDT codes in addition to endoscopy/bronchoscopy

Background & Evidence Summary

Background: The FDA has approved porfimer sodium (Photofrin) with specified laser systems for treatment of early-stage microinvasive lung cancer and for palliation/relief of obstruction in completely or partially obstructing endobronchial non-small cell lung cancer. PDT has been evaluated as an alternative to esophagectomy for Barrett's esophagus and as adjunctive palliation with stenting for unresectable cholangiocarcinoma, with randomized trials reporting improved survival in some studies. For superficial non-melanoma skin cancers, topical photosensitizers (e.g., ALA, MAL) have evidence of effectiveness; systemic (intravenous) photosensitizers for skin indications are generally avoided because they can cause prolonged photosensitivity.

Background evidence summaries (major themes):

• Dermatologic/pre-malignant skin lesions: multiple systematic reviews and RCTs report PDT efficacy for Bowen disease (pooled clearance ~76%) and more limited/heterogeneous results for cutaneous SCC (pooled clearance ~51%) and nodular BCC (higher recurrence vs excision but better cosmetic outcomes).

• Wound healing and antimicrobial effects: systematic reviews of human and animal studies suggest PDT can reduce bacterial counts, stimulate fibroblasts and collagen, and accelerate healing, but data are heterogeneous and largely from small or preclinical studies.

• Endodontic/periodontal infections and peri-implant disease: multiple meta-analyses and systematic reviews report mixed or limited benefit of adjunctive antimicrobial PDT (aPDT) with some short-term microbial load reductions and small clinical gains; high heterogeneity and limited high-quality RCTs.

• Cervical intraepithelial neoplasia/HPV: meta-analysis of RCTs showed increased complete response and HPV clearance with PDT (ORs reported) but overall evidence quality rated very low and higher adverse event rates were observed.

Definitions

Definitions:

PDT — Photodynamic therapy: light-based therapy following administration of a photosensitizing agent to induce localized tissue necrosis or antimicrobial effect.

Revision History

2000-01-31Effective Date

Policy effective date as listed in the Clinical Policy Bulletin.

2023-06-21Last ReviewLatest

Most recent policy review date listed in the Clinical Policy Bulletin.

2024-04-11Next Review

Next scheduled policy review date as listed in the Clinical Policy Bulletin.

Policy Summary

PayerAetna

PolicyPhotodynamic Therapy

Policy CodePolicy 0375

Change TypeNo material change

Effective DateJan 31, 2000

Next Review DateApr 11, 2024

SourceLink

On This Page

Completely obstructing endobronchial non-small cell lung cancer.

Microinvasive endobronchial non-small cell lung cancer at an early stage, for whom surgery and radiotherapy are not indicated.

Partially obstructing endobronchial non-small cell lung cancer.

Non-melanoma Skin Tumors - Medical Necessity (topical photosensitizers)

ONE of

Basal cell carcinoma.
Cutaneous lesions of Bowen's disease (carcinoma in situ of skin).
Refractory actinic keratoses.

Other covered skin indications using specified agents

Photodynamic therapy using methyl aminolevulinate for low-risk squamous cell carcinoma in-situ where surgery or radiation is contraindicated or impractical.
Photodynamic therapy using aminolevulinic acid or methyl aminolevulinate for erythroplasia of Queyrat.

Not covered with intravenous photosensitizers for skin indications

Photodynamic therapy using intravenous photosensitizers (e.g., porfimer sodium) for the skin indications listed above is considered experimental and investigational.

Cholangiocarcinoma - Medical Necessity

Covered when used as an adjunct:

ALL of the following

Photodynamic therapy used as an adjunct to stenting for palliation of inoperable cholangiocarcinoma.

Background Evidence Summaries

Photodynamic therapy (PDT) uses a photosensitizing agent activated by light to produce reactive oxygen species that destroy targeted tissue. Agents include intravenous porfimer sodium (Photofrin) for internal malignancies and topical aminolevulinic acid or methyl aminolevulinate for cutaneous lesions.
For esophageal and endobronchial tumors, PDT has been used for palliation of obstructing lesions and for treatment of superficial or microinvasive disease when surgery or radiotherapy are not options; evidence includes case series and nonrandomized studies demonstrating symptomatic relief and tumor ablation, though randomized comparative data are limited.
For non-melanoma skin tumors, topical PDT with aminolevulinic acid or methyl aminolevulinate has demonstrated efficacy for superficial basal cell carcinoma, Bowen's disease, refractory actinic keratoses, and selected in-situ squamous cell carcinomas when other treatments are contraindicated or impractical; outcomes include lesion clearance and cosmetic benefits in multiple clinical trials and systematic reviews.
For cholangiocarcinoma, small randomized and nonrandomized studies suggest PDT combined with biliary stenting can improve biliary drainage and may prolong survival or quality of life compared with stenting alone, supporting its role as an adjunct for palliation in inoperable cases.
PDT is considered experimental and investigational for numerous other cancer and non-cancer indications due to insufficient or conflicting evidence regarding effectiveness. Safety considerations include photosensitivity reactions, procedure-related local tissue injury, and potential need for repeat treatments; agent- and indication-specific adverse effects are described in the literature.

Intra-ocular choroidal metastases

Mediastinal carcinoid tumor

Pleural mesothelioma

Peritoneal carcinomatosis

Prostate cancer (interstitial motexafin lutetium-mediated PDT)

Retinal hamartomas/tuberous sclerosis

Squamous cell carcinoma in the head and neck

Squamous dysplasia of the oral cavity

Experimental and Investigational - Non-Cancer Indications (Not Covered)

PDT is considered experimental and investigational for ANY of the following non-cancer indications:

ANY of the following

Actinic cheilitis
Actinic dermatitis
Atopic dermatitis (eczematous dermatitis)
Central serous chorioretinopathy
Chronic rhinosinusitis
Chronic ulcers (including diabetic ulcers)
Condyloma (genital warts)
Darier's disease (keratosis follicularis)
Disseminated superficial actinic porokeratosis
Dyspigmentation
Endodontic infections
Extra-mammary Paget's disease (e.g., Paget's disease of the vulva)
Granulomatous dermatitis
Halitosis
Herpes labialis
Hidradenitis suppurativa
Human papilloma virus infection
Liposclerosis (lipodermatosclerosis)
Keratitis
Nekam's disease (keratosis lichenoides chronica)
Onychomycosis
Oral leucoplakia / leukoplakia
Oral lichen planus
Peri-implantitis / peri-implant mucositis
Periodontitis
Photoaging
Plantar wart
Psoriasis
Radiation retinopathy
Respiratory papillomatosis
Rosacea
SARS-CoV-2 (COVID-19)
Scarring
Sebaceous hyperplasia
Superficial mycosis
Type II diabetes mellitus
Verrucous vulgaris (common wart) of the face
Vulvar lichen sclerosus
Wound healing

When performing endoscopic PDT procedures of the lung or esophagus, report the PDT time-based CPT codes separately in addition to the code for the endoscopy or bronchoscopy procedure. These codes are listed in the policy and should be billed separately from the scope procedure.

96570
96571
Report 96570/96571 in addition to the endoscopy/bronchoscopy procedure code

Billing Rule

Topical PDT per day/session coding

For external (topical) PDT of skin and adjacent mucosa, use the CPT codes designated for external photodynamic therapy; note that two of these codes are reported per day when applicable.

96567
96573
96574
96573 and 96574 are reported per day

Billing Rule

Drug coding for photosensitizers

Use the HCPCS/J-codes specified for photosensitizing agents when selection criteria for coverage are met. Include the intravenous porfimer sodium code and the topical aminolevulinic acid product codes as applicable and distinguish topical versus systemic usage per policy.

J9600
J7308
J7345
Note: topical photosensitizers (J7308, J7345) are for topical ALA/MAL; J9600 is porfimer sodium (systemic)

Documentation Required

Policy effective and review dates

Include the policy effective date, the most recent review date, and the scheduled next review in documentation and when checking policy applicability.

Effective date: 2000-01-31
Last review date: 2023-06-21
Next review date: 2024-04-11

• Oral leukoplakia and other oral premalignant lesions: systematic reviews indicate PDT may be useful as a non-surgical option with variable complete/partial response rates and need for standardized PDT parameters and more RCTs.

• Ophthalmologic indications (e.g., chronic central serous chorioretinopathy, wet AMD combinations): trials/meta-analyses show short-term benefits (e.g., reduced subretinal fluid, fewer injections when combined therapy used) but mixed effects on vision outcomes and limited long-term data.

• Actinic cheilitis and other cutaneous precancerous conditions: case series and systematic reviews report clinical responses with variable histologic cure; daylight-PDT may be better tolerated; evidence limited and heterogeneous.

• Other indications (lichen sclerosus, herpes labialis, dyspigmentation/photoaging/scarring, chronic rhinosinusitis, SARS-CoV-2 inactivation, peritoneal carcinomatosis, mesothelioma, brain tumors, extra-mammary Paget's disease, peri-implantitis): substantial literature exists but consists largely of small studies, case series, or preclinical data; many uses remain investigational with predominantly low-quality, heterogeneous evidence and a need for larger, well-designed RCTs.

Study / Topic	Key finding
Ortner et al (2003) RCT for cholangiocarcinoma
PDT + stenting prolonged median survival: 493 days vs 98 days (p < 0.0001)
Zoepf et al (2005) RCT (phase IIb) for cholangiocarcinoma
Median survival 21 months with PDT vs 7 months control (p = 0.0109); higher cholangitis rate in PDT group
Rhodes et al (2007) RCT MAL-PDT vs excision for nodular BCC
5-year recurrence 14% MAL-PDT vs 4% excision; cosmetic outcomes better with PDT
Zhang 2018 meta-analysis (CIN/HPV pooled ORs)
PDT increased complete response: OR 2.51 for CIN and OR 3.82 for HPV; higher AE rate (OR 13.32); overall evidence very low
Yongpisarn 2022 pooled clearance (Bowen disease / cSCC)
Pooled clearance: Bowen disease 76% (95% CI: 71%–80%); cutaneous SCC 51% (95% CI: 35%–66%)
References count: 163+